Senior Regulator Associate

Provide Regulatory Support for Current Products and Development Projects
• Execute strategy and provide regulatory support and input. Deliver projects and other initiatives to progress current product portfolio by providing regulatory direction and support to stakeholders:
• Collect and collate data required for registration submissions.
• Prepare submission packages for the appropriate Regulatory Agency.
• Correspond with the appropriate Federal or State Agency regarding registration submissions.
• Review product labeling and supporting materials.

Implement New Regulations and Guidances
• Assess impact of new regulations and guidances.
• Work with stakeholders to implement requirements within specified timelines.
• Keep current with all relevant guidances and regulations while monitoring any changes that occur
• Assess and communicate all requirements to stakeholders in order to maintain compliance without delay to business due to regulatory issues.
• Adjust and monitor timelines to support the business.

Support Infrastructure and Systems Integration
• Contribute to supporting a high quality and effective infrastructure to meet the regulatory requirements which support the launch of associated products.
• Execute systems integration for optimal functionality and use.
• Contribution to infrastructure (processes, procedures, systems etc.) to be made within agreed upon timelines.
• Deliver project and brand specific activities assuring they are correct, complete and on-time including registrations, submissions, labeling/advertising initiation/reviews, etc.

Gain Understanding of Legislative and Regulatory Climate
• Understand how the government operates and key touch points to influence policy development. Monitor trade associations and task forces.
• Monitor ongoing legislative and competitive developments.
• Monitor and gain an understanding of new policies and objectives involving federal and local government affairs.
• Review trade association materials (newsletters, meeting minutes, agenda items) to gain an understanding of where influencing opportunities exist.

• BA/BS degree required in the natural sciences.
• A minimum of 3 years of relevant work experience required.
• Experience with either EPA or FDA registered products is required.
• Experience in consumer products industry is highly preferred (a must if only experience is R&D).
• High attention to detail and strong organization skills
• Ability to establish close communications and working relationship with cross functional teams to meet business objectives
• Ability to work with uncertainties and effect innovative solutions to complex regulatory requirements
• Strong verbal and written communication skills
• Strong negotiating, influencing and interpersonal skills
• Results oriented, entrepreneurial and self-motivated
• Excellent computer skills (Microsoft Office suite)

Christie Mathew

christie @irionline.com

7328448739